Systems and methods for endometrial albation

ABSTRACT

A device for endometrial ablation having an elongated shaft with a working end comprising an expandable-contractable frame, a complaint energy-delivery surface carried by the frame, the surface and the frame being configured to engage against the interior of a patient&#39;s uterine cavity when the working end is inserted into the cavity and the frame is expanded.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/885,854 (Attorney Docket No. 37646-714.301), filed Oct. 16, 2015,which is a continuation of U.S. patent application Ser. No. 13/667,774(Attorney Docket No. 37646-714.501), filed Nov. 2, 2012, which is acontinuation-in-part of U.S. patent application Ser. No. 13/267,258(Attorney Docket No. 37646-714.201), filed Oct. 6, 2011, which claimsthe benefit of Provisional Application No. 61/394,693 (Attorney DocketNo. 37646-714.101), filed Oct. 19, 2010; this application also claimspriority to Provisional Application No. 61/556,675 (Attorney Docket No.37646-714.102), filed Nov. 7, 2011, the entire contents of each areincorporated herein by reference.

The specification of this provisional application includes FIGS. 1-20and the associated text from non-provisional application Ser. No.13/267,258 (Attorney Docket No. 37646-714.201), the full disclosure ofwhich is incorporated herein by reference. The non-provisional filing ofthis provisional application may be a continuation-in-part ofapplication Ser. No. 13/267,258.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to electrosurgical methods and devices forglobal endometrial ablation in a treatment of menorrhagia. Moreparticularly, the present invention relates to applying radiofrequencycurrent to endometrial tissue by means of capacitively coupling thecurrent through an expandable, thin-wall dielectric member enclosing anionized gas.

A variety of devices have been developed or proposed for endometrialablation. Of relevance to the present invention, a variety ofradiofrequency ablation devices have been proposed including solidelectrodes, balloon electrodes, metalized fabric electrodes, and thelike. While often effective, many of the prior electrode designs havesuffered from one or more deficiencies, such as relatively slowtreatment times, incomplete treatments, non-uniform ablation depths, andrisk of injury to adjacent organs.

For these reasons, it would be desirable to provide systems and methodsthat allow for endometrial ablation using radiofrequency current whichis rapid, provides for controlled ablation depth and which reduce therisk of injury to adjacent organs. At least some of these objectiveswill be met by the invention described herein.

2. Description of the Background Art

U.S. Pat. Nos. 5,769,880; 6,296,639; 6,663,626; and 6,813,520 describeintrauterine ablation devices formed from a permeable mesh definingelectrodes for the application of radiofrequency energy to ablateuterine tissue. U.S. Pat. No. 4,979,948 describes a balloon filled withan electrolyte solution for applying radiofrequency current to a mucosallayer via capacitive coupling. US 2008/097425, having commoninventorship with the present application, describes delivering apressurized flow of a liquid medium which carries a radiofrequencycurrent to tissue, where the liquid is ignited into a plasma as itpasses through flow orifices. U.S. Pat. No. 5,891,134 describes aradiofrequency heater within an enclosed balloon. U.S. Pat. No.6,041,260 describes radiofrequency electrodes distributed over theexterior surface of a balloon which is inflated in a body cavity to betreated. U.S. Pat. No. 7,371,231 and US 2009/054892 describe aconductive balloon having an exterior surface which acts as an electrodefor performing endometrial ablation. U.S. Pat. No. 5,191,883 describesbipolar heating of a medium within a balloon for thermal ablation. U.S.Pat. Nos. 6,736,811 and 5,925,038 show an inflatable conductiveelectrode.

BRIEF SUMMARY OF THE INVENTION

The present invention provides methods and systems for performingendometrial ablation for the treatment uterine diseases in humanfemales. In a first aspect, the present invention provides systems forendometrial ablation where the systems comprise a shaft with anexpandable-contractible frame mounted thereon. A compliantenergy-delivery surface is carried by the frame, and the surface definesan interior chamber when expanded by the frame. The frame is configuredto engage the surface against an interior wall or other portion of thepatient's uterine cavity when the working end of the shaft is insertedinto the cavity and the frame is expanded. The exterior surface carriesan electrode in order to delivery energy into the uterine wall forablation or other therapeutic use.

In an exemplary embodiment, the system is configured so that theexpandable contractible frame provides a primary or initial expansion ofthe compliant energy-delivery surface in a lateral direction byexpanding the frame within the interior chamber. The system ispreferably further configured to provide for a secondary expansion ofthe energy-delivery surface by inflating the interior chamber to causethe surface to expand in an anterior-posterior direction, i.e. adirection which is generally perpendicular or normal to the lateraldirection defined by the frame when it opens.

In a second aspect of the present invention, the energy-delivery surfacecomprises a thin-walled elastomer, such as a silicone elastomer, wherethe electrode structure is optionally molded into the outer surface ofthe elastomer. The thin-walled elastomer preferably circumscribes theexpandable-contractible frame to define the interior chamber thereinwhen the frame is expanded. Such structure is particularly suitable forthe two-stage expansion described above where the frame first expandsthe elastomeric chamber laterally and an inflation of the chamberexpands the wall of the chamber in an anterior-posterior direction.

The systems of the present invention may further comprise a fluidpressure source coupled to the interior chamber. The systems may stillfurther comprise at least one temperature sensor carried on or near theenergy-delivery surface. The systems will usually also comprise acontroller operatively coupled to the temperature sensor and/or thefluid pressure source. The controller allows automatic and/or manualcontrol of inflation and/or energy delivery protocols for therapeutictreatments according to the present invention.

Methods according to the present invention for treating a patient'suterus comprise positioning a probe in the patient's uterine cavity,typically by trans-cervically introducing the probe or, alternatively,by laparoscopic or other minimally invasive introduction techniques. Aprobe end is then expanded in a primary or first direction by actuatinga frame within an anterior portion of the probe end. The probe end isthen expanded in a second direction by introducing a fluid medium intothe interior chamber. The twice-expanded probe end may then be used todeliver energy into the uterine cavity, typically into a wall of theuterine cavity to achieve therapeutic ablation. The delivered energy maybe radiofrequency (RF) energy which is delivered from one or a pluralityof electrodes present on the expanded surface, usually an exteriorsurface of the balloon. The RF energy may be monopolar or may bedelivered by bipolar electrodes carried by the probe end. Alternatively,the energy may be delivered by capacitive coupling of a currentdelivered through the probe end. The first direction of the balloonexpansion is preferably in a direction laterally across the uterinecavity and is typically achieved by frame actuation while the seconddirection is usually achieved by inflation of the probe end and lies ina direction along an anterior-posterior axis.

In a further method according to the present invention, endometrialablation is performed by trans-cervical introduction of a probe workingend into a patient's uterine cavity. The probe working end comprises anexpandable-contractible frame which carries a compliant energy-deliverysurface. The frame is actuated to expand the energy-deliver surfacewithin the uterine cavity, and an inflation medium is then delivered toan interior chamber within the working end to further expand the energydelivery surface. Energy is delivered from the energy-delivery surfacein order to effect the desired endometrial ablation or other therapeutictreatment. Usually, the frame expands the energy-delivery surface in thea plane which is generally laterally oriented within the uterus, whileinflation expands the surface in a direction generally transverse to alateral direction, i.e., in an anterior-posterior direction. Theinflation source will typically deliver a very low inflation pressure,usually above 20 mm Hg (in the range from 20 mm Hg to 100 mm Hg),sometimes above 30 mm Hg (in the range from 30 mm Hg to 100 mm Hg),often above 40 mm Hg (in the range from 40 mm Hg to 100 mm Hg), andoccasionally over 50 mm Hg (in the range from 50 mm Hg to 100 mm Hg).Such low inflation levels have been found to be sufficient to expand theworking end of the probes to fully engage the energy-delivery surfaceagainst the wall of the uterine cavity and provide efficient energydelivery, from electrode contact, inductive current coupling, or otherenergy delivery modes. In specific embodiments, an inflation chamberwithin the working end surrounded by a thin-walled elastomer is createdby circulating a gas stream within the chamber under conditions whichmaintain a pressure in the interior chamber within the ranges set forthabove.

In yet a further aspect of the present invention, a method forperforming endometrial ablation comprises trans-cervically introducing aprobe working end into a patient's uterine cavity. A thin-walledenergy-delivery surface on the working end is then expanded within theuterine cavity, and energy is delivered from the expanded surface tocause endometrial ablation. The depth of ablation may then be monitoredby an ultrasonic transducer which is carried by or within the workingend of the probe.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand the invention and to see how it may becarried out in practice, some preferred embodiments are next described,by way of non-limiting examples only, with reference to the accompanyingdrawings, in which like reference characters denote correspondingfeatures consistently throughout similar embodiments in the attacheddrawings.

FIG. 1 is a perspective view of an ablation system corresponding to theinvention, including a hand-held electrosurgical device for endometrialablation, RF power source, gas source and controller.

FIG. 2 is a view of the hand-held electrosurgical device of FIG. 1 witha deployed, expanded thin-wall dielectric structure.

FIG. 3 is a block diagram of components of one electrosurgical systemcorresponding to the invention.

FIG. 4 is a block diagram of the gas flow components of theelectrosurgical system of FIG. 1.

FIG. 5 is an enlarged perspective view of the expanded thin-walldielectric structure, showing an expandable-collapsible frame with thethin dielectric wall in phantom view.

FIG. 6 is a partial sectional view of the expanded thin-wall dielectricstructure of FIG. 5 showing (i) translatable members of theexpandable-collapsible frame a that move the structure between collapsedand (ii) gas inflow and outflow lumens.

FIG. 7 is a sectional view of an introducer sleeve showing variouslumens of the introducer sleeve taken along line 7-7 of FIG. 6.

FIG. 8A is an enlarged schematic view of an aspect of a method of theinvention illustrating the step introducing an introducer sleeve into apatient's uterus.

FIG. 8B is a schematic view of a subsequent step of retracting theintroducer sleeve to expose a collapsed thin-wall dielectric structureand internal frame in the uterine cavity.

FIG. 8C is a schematic view of subsequent steps of the method,including, (i) actuating the internal frame to move the a collapsedthin-wall dielectric structure to an expanded configuration, (ii)inflating a cervical-sealing balloon carried on the introducer sleeve,and (iii) actuating gas flows and applying RF energy tocontemporaneously ionize the gas in the interior chamber and causecapacitive coupling of current through the thin-wall dielectricstructure to cause ohmic heating in the engaged tissue indicated bycurrent flow paths.

FIG. 8D is a schematic view of a subsequent steps of the method,including: (i) advancing the introducer sleeve over the thin-walldielectric structure to collapse it into an interior bore shown inphantom view, and (ii) withdrawing the introducer sleeve and dielectricstructure from the uterine cavity.

FIG. 9 is a cut-away perspective view of an alternative expandedthin-wall dielectric structure similar to that of FIGS. 5 and 6 show analternative electrode configuration.

FIG. 10 is an enlarged cut-away view of a portion of the expandedthin-wall dielectric structure of FIG. 9 showing the electrodeconfiguration.

FIG. 11 is a diagram of a radiofrequency energy delivery apparatus andmethod corresponding to the invention.

FIG. 12 is a schematic view of the working end of the ablation device ofFIGS. 1-2 depicting three outlines of the expandable working end in arange of slightly-expanded to fully-expanded positions.

FIG. 13A is a schematic representation of an indicator mechanism in thehandle of the ablation device of FIGS. 1-2 for indicating a first degreeof expansion of the dielectric structure in a range shown in FIG. 12.

FIG. 13B is a schematic representation of the indicator mechanism ofFIG. 13A indicating a second the degree of expansion of the dielectricstructure.

FIG. 14A is a schematic view of another embodiment of an expandableworking end that is frame-expandable and carries a bi-polar electrodearrangement.

FIG. 14B is a cut-away view of the expandable working end of FIG. 14Ashowing the expandable frame.

FIG. 15 is an enlarged sectional view of the flex-circuit electrodeintegrated into an expandable surface of the working end of FIG. 14A.

FIG. 16 is a schematic view of an alternative frame-expandable workingend that includes apertures in the surface in communication with anegative pressure source.

FIG. 17 is a schematic view of an alternative frame-expandable workingend that includes apertures in the surface in communication with anegative pressure source.

FIG. 18 illustrates another embodiment of a working end in accordancewith the principles of the present invention.

FIG. 19A is a sectional view of the working end of FIG. 18 taken alongline 19A-19A with the dielectric membrane expanded in lateral directionsby the interior frame.

FIG. 19B is a sectional view of the working end of FIG. 19A showingexpansion of the dielectric membrane with an inflation medium to expandthe membrane in a second direction.

FIG. 20 is a cut-away view of another working end showing the dielectricmembrane molded with soft distal tips.

FIG. 21 is a sectional view of another working end that illustrate (i)the dissimilar properties of inner and outer frame elements used toexpand the dielectric membrane, and (ii) the modified shape of thedielectric membrane provided by such frame elements.

DETAILED DESCRIPTION

In general, an electrosurgical ablation system is described herein thatcomprises an elongated introducer member for accessing a patient'suterine cavity with a working end that deploys an expandable thin-walldielectric structure containing an electrically non-conductive gas as adielectric. In one embodiment, an interior chamber of the thin-walldielectric structure contains a circulating neutral gas such as argon.An RF power source provides current that is coupled to the neutral gasflow by a first polarity electrode disposed within the interior chamberand a second polarity electrode at an exterior of the working end. Thegas flow, which is converted to a conductive plasma by an electrodearrangement, functions as a switching mechanism that permits currentflow to engaged endometrial tissue only when the voltage across thecombination of the gas, the thin-wall dielectric structure and theengaged tissue reaches a threshold that causes capacitive couplingacross the thin-wall dielectric material. By capacitively couplingcurrent to tissue in this manner, the system provides a substantiallyuniform tissue effect within all tissue in contact with the expandeddielectric structure. Further, the invention allows the neutral gas tobe created contemporaneously with the capacitive coupling of current totissue.

In general, this disclosure may use the terms “plasma,” “conductive gas”and “ionized gas” interchangeably. A plasma consists of a state ofmatter in which electrons in a neutral gas are stripped or “ionized”from their molecules or atoms. Such plasmas can be formed by applicationof an electric field or by high temperatures. In a neutral gas,electrical conductivity is non-existent or very low. Neutral gases actas a dielectric or insulator until the electric field reaches abreakdown value, freeing the electrons from the atoms in an avalancheprocess thus forming a plasma. Such a plasma provides mobile electronsand positive ions, and acts as a conductor which supports electriccurrents and can form spark or arc. Due to their lower mass, theelectrons in a plasma accelerate more quickly in response to an electricfield than the heavier positive ions, and hence carry the bulk of thecurrent.

FIG. 1 depicts one embodiment of an electrosurgical ablation system 100configured for endometrial ablation. The system 100 includes a hand-heldapparatus 105 with a proximal handle 106 shaped for grasping with ahuman hand that is coupled to an elongated introducer sleeve 110 havingaxis 111 that extends to a distal end 112. The introducer sleeve 110 canbe fabricated of a thin-wall plastic, composite, ceramic or metal in around or oval cross-section having a diameter or major axis ranging fromabout 4 mm to 8 mm in at least a distal portion of the sleeve thataccesses the uterine cavity. The handle 106 is fabricated of anelectrically insulative material such as a molded plastic with apistol-grip having first and second portions, 114 a and 114 b, that canbe squeezed toward one another to translate an elongated translatablesleeve 115 which is housed in a bore 120 in the elongated introducersleeve 110. By actuating the first and second handle portions, 114 a and114 b, a working end 122 can be deployed from a first retracted position(FIG. 1) in the distal portion of bore 120 in introducer sleeve 110 toan extended position as shown in FIG. 2. In FIG. 2, it can be seen thatthe first and second handle portions, 114 a and 114 b, are in a secondactuated position with the working end 122 deployed from the bore 120 inintroducer sleeve 110.

FIGS. 2 and 3 shows that ablation system 100 includes an RF energysource 130A and RF controller 130B in a control unit 135. The RF energysource 130A is connected to the hand-held device 105 by a flexibleconduit 136 with a plug-in connector 137 configured with a gas inflowchannel, a gas outflow channel, and first and second electrical leadsfor connecting to receiving connector 138 in the control unit 135. Thecontrol unit 135, as will be described further below in FIGS. 3 and 4,further comprises a neutral gas inflow source 140A, gas flow controller140B and optional vacuum or negative pressure source 145 to providecontrolled gas inflows and gas outflows to and from the working end 122.The control unit 135 further includes a balloon inflation source 148 forinflating an expandable sealing balloon 225 carried on introducer sleeve110 as described further below.

Referring to FIG. 2, the working end 122 includes a flexible, thin-wallmember or structure 150 of a dielectric material that when expanded hasa triangular shape configured for contacting the patient's endometriallining that is targeted for ablation. In one embodiment as shown inFIGS. 2, 5 and 6, the dielectric structure 150 comprises a thin-wallmaterial such as silicone with a fluid-tight interior chamber 152.

In an embodiment, an expandable-collapsible frame assembly 155 isdisposed in the interior chamber. Alternatively, the dielectricstructure may be expanded by a neutral gas without a frame, but using aframe offers a number of advantages. First, the uterine cavity isflattened with the opposing walls in contact with one another. Expandinga balloon-type member may cause undesirable pain or spasms. For thisreason, a flat structure that is expanded by a frame is better suitedfor deployment in the uterine cavity. Second, in embodiments herein, theneutral gas is converted to a conductive plasma at a very low pressurecontrolled by gas inflows and gas outflows—so that any pressurization ofa balloon-type member with the neutral gas may exceed a desired pressurerange and would require complex controls of gas inflows and gasoutflows. Third, as described below, the frame provides an electrode forcontact with the neutral gas in the interior chamber 152 of thedielectric structure 150, and the frame 155 extends into all regions ofthe interior chamber to insure electrode exposure to all regions of theneutral gas and plasma. The frame 155 can be constructed of any flexiblematerial with at least portions of the frame functioning as springelements to move the thin-wall structure 150 from a collapsedconfiguration (FIG. 1) to an expanded, deployed configuration (FIG. 2)in a patient's uterine cavity. In one embodiment, the frame 155comprises stainless steel elements 158 a, 158 b and 160 a and 160 b thatfunction akin to leaf springs. The frame can be a stainless steel suchas 316 SS, 17A SS, 420 SS, 440 SS or the frame can be a NiTi material.The frame preferably extends along a single plane, yet remains thintransverse to the plane, so that the frame may expand into the uterinecavity. The frame elements can have a thickness ranging from about0.005″ to 0.025″. As can be seen in FIGS. 5 and 6, the proximal ends 162a and 162 b of spring elements 158 a, 158 b are fixed (e.g., by welds164) to the distal end 165 of sleeve member 115. The proximal ends 166 aand 166 b of spring elements 160 a, 160 b are welded to distal portion168 of a secondary translatable sleeve 170 that can be extended frombore 175 in translatable sleeve 115. The secondary translatable sleeve170 is dimensioned for a loose fit in bore 175 to allow gas flows withinbore 175. FIGS. 5 and 6 further illustrate the distal ends 176 a and 176b of spring elements 158 a, 158 b are welded to distal ends 178 a and178 b of spring elements 160 a and 160 b to thus provide a frame 155that can be moved from a linear shape (see FIG. 1) to an expandedtriangular shape (FIGS. 5 and 6).

As will be described further below, the bore 175 in sleeve 115 and bore180 in secondary translatable sleeve 170 function as gas outflow and gasinflow lumens, respectively. It should be appreciated that the gasinflow lumen can comprise any single lumen or plurality of lumens ineither sleeve 115 or sleeve 170 or another sleeve, or other parts of theframe 155 or the at least one gas flow lumen can be formed into a wallof dielectric structure 150. In FIGS. 5, 6 and 7 it can be seen that gasinflows are provided through bore 180 in sleeve 170, and gas outflowsare provided in bore 175 of sleeve 115. However, the inflows andoutflows can be also be reversed between bores 175 and 180 of thevarious sleeves. FIGS. 5 and 6 further show that a rounded bumperelement 185 is provided at the distal end of sleeve 170 to insure thatno sharp edges of the distal end of sleeve 170 can contact the inside ofthe thin dielectric wall 150. In one embodiment, the bumper element 185is silicone, but it could also comprise a rounded metal element. FIGS. 5and 6 also show that a plurality of gas inflow ports 188 can be providedalong a length of in sleeve 170 in chamber 152, as well as a port 190 inthe distal end of sleeve 170 and bumper element 185. The sectional viewof FIG. 7 also shows the gas flow passageways within the interior ofintroducer sleeve 110.

It can be understood from FIGS. 1, 2, 5 and 6 that actuation of firstand second handle portions, 114 a and 114 b, (i) initially causesmovement of the assembly of sleeves 115 and 170 relative to bore 120 ofintroducer sleeve 110, and (ii) secondarily causes extension of sleeve170 from bore 175 in sleeve 115 to expand the frame 155 into thetriangular shape of FIG. 5. The dimensions of the triangular shape aresuited for a patient uterine cavity, and for example can have an axiallength A ranging from 4 to 10 cm and a maximum width B at the distal endranging from about 2 to 5 cm. In one embodiment, the thickness C of thethin-wall structure 150 can be from 1 to 4 mm as determined by thedimensions of spring elements 158 a, 158 b, 160 a and 160 b of frameassembly 155. It should be appreciated that the frame assembly 155 cancomprise round wire elements, flat spring elements, of any suitablemetal or polymer that can provide opening forces to move thin-wallstructure 150 from a collapsed configuration to an expandedconfiguration within the patient uterus. Alternatively, some elements ofthe frame 155 can be spring elements and some elements can be flexiblewithout inherent spring characteristics.

As will be described below, the working end embodiment of FIGS. 2, 5 and6 has a thin-wall structure 150 that is formed of a dielectric materialsuch as silicone that permits capacitive coupling of current to engagedtissue while the frame assembly 155 provides structural support toposition the thin-wall structure 150 against tissue. Further, gasinflows into the interior chamber 152 of the thin-wall structure canassist in supporting the dielectric wall so as to contact endometrialtissue. The dielectric thin-wall structure 150 can be free from fixationto the frame assembly 155, or can be bonded to an outward-facing portionor portions of frame elements 158 a and 158 b. The proximal end 182 ofthin-wall structure 150 is bonded to the exterior of the distal end ofsleeve 115 to thus provide a sealed, fluid-tight interior chamber 152(FIG. 5).

In one embodiment, the gas inflow source 140A comprises one or morecompressed gas cartridges that communicate with flexible conduit 136through plug-in connector 137 and receiving connector 138 in the controlunit 135 (FIGS. 1-2). As can be seen in FIGS. 5-6, the gas inflows fromsource 140A flow through bore 180 in sleeve 170 to open terminations 188and 190 therein to flow into interior chamber 152. A vacuum source 145is connected through conduit 136 and connector 137 to allow circulationof gas flow through the interior chamber 152 of the thin-wall dielectricstructure 150. In FIGS. 5 and 6, it can be seen that gas outflowscommunicate with vacuum source 145 through open end 200 of bore 175 insleeve 115. Referring to FIG. 5, it can be seen that frame elements 158a and 158 b are configured with a plurality of apertures 202 to allowfor gas flows through all interior portions of the frame elements, andthus gas inflows from open terminations 188, 190 in bore 180 are free tocirculated through interior chamber 152 to return to an outflow paththrough open end 200 of bore 175 of sleeve 115. As will be describedbelow (see FIGS. 3-4), the gas inflow source 140A is connected to a gasflow or circulation controller 140B which controls a pressure regulator205 and also controls vacuum source 145 which is adapted for assistingin circulation of the gas. It should be appreciated that the frameelements can be configured with apertures, notched edges or any otherconfigurations that allow for effective circulation of a gas throughinterior chamber 152 of the thin-wall structure 150 between the inflowand outflow passageways.

Now turning to the electrosurgical aspects of the invention, FIGS. 5 and6 illustrate opposing polarity electrodes of the system 100 that areconfigured to convert a flow of neutral gas in chamber 152 into a plasma208 (FIG. 6) and to allow capacitive coupling of current through a wall210 of the thin-wall dielectric structure 150 to endometrial tissue incontact with the wall 210. The electrosurgical methods of capacitivelycoupling RF current across a plasma 208 and dielectric wall 210 to causeJoule heating in tissue and to conductively heat tissue from thedielectric are described in U.S. patent application Ser. No. 12/541,043filed Aug. 13, 2009; U.S. application Ser. No. 12/541,050 filed Aug. 13,2009; U.S. patent application Ser. No. 12/605,546 filed Oct. 26, 2009;U.S. patent application Ser. No. 12/605,929 filed Oct. 26, 2009 and U.S.application Ser. No. 12/944,466 filed Nov. 11, 2010. In FIGS. 5 and 6,the first polarity electrode 215 is within interior chamber 152 tocontact the neutral gas flow and comprises the frame assembly 155 thatis fabricated of an electrically conductive stainless steel. In anotherembodiment, the first polarity electrode can be any element disposedwithin the interior chamber 152, or extendable into interior chamber152. The first polarity electrode 215 is electrically coupled to sleeves115 and 170 which extends through the introducer sleeve 110 to handle106 and conduit 136 and is connected to a first pole of the RF sourceenergy source 130A and controller 130B. A second polarity electrode 220is external of the internal chamber 152 and in one embodiment theelectrode is spaced apart from wall 210 of the thin-wall dielectricstructure 150. In one embodiment as depicted in FIGS. 5 and 6, thesecond polarity electrode 220 comprises a surface element of anexpandable balloon member 225 carried by introducer sleeve 110. Thesecond polarity electrode 220 is coupled by a lead (not shown) thatextends through the introducer sleeve 110 and conduit 136 to a secondpole of the RF source 130A. It should be appreciated that secondpolarity electrode 220 can be positioned on sleeve 110 or can beattached to surface portions of the expandable thin-wall dielectricstructure 150, as will be described below, to provide suitable contactwith body tissue to allow the electrosurgical ablation of the method ofthe invention. The second polarity electrode 220 can comprise a thinconductive metallic film, thin metal wires, a conductive flexiblepolymer or a polymeric positive temperature coefficient material. In oneembodiment depicted in FIGS. 5 and 6, the expandable member 225comprises a thin-wall compliant balloon having a length of about 1 cm to6 cm that can be expanded to seal the cervical canal. The balloon 225can be inflated with a gas or liquid by any inflation source 148, andcan comprise a syringe mechanism controlled manually or by control unit135. The balloon inflation source 148 is in fluid communication with aninflation lumen 228 in introducer sleeve 110 that extends to aninflation chamber of balloon 225 (see FIG. 7).

Referring back to FIG. 1, the control unit 135 can include a display 230and touch screen or other controls 232 for setting and controllingoperational parameters such as treatment time intervals, treatmentalgorithms, gas flows, power levels and the like. Suitable gases for usein the system include argon, other noble gases and mixtures thereof. Inone embodiment, a footswitch 235 is coupled to the control unit 135 foractuating the system.

The box diagrams of FIGS. 3 and 4 schematically depict the system 100,subsystems and components that are configured for an endometrialablation system. In the box diagram of FIG. 3, it can be seen that RFenergy source 130A and circuitry is controlled by a controller 130B. Thesystem can include feedback control systems that include signalsrelating to operating parameters of the plasma in interior chamber 152of the dielectric structure 150. For example, feedback signals can beprovided from at least one temperature sensor 240 in the interiorchamber 152 of the dielectric structure 150, from a pressure sensorwithin, or in communication, with interior chamber 152, and/or from agas flow rate sensor in an inflow or outflow channel of the system. FIG.4 is a schematic block diagram of the flow control components relatingto the flow of gas media through the system 100 and hand-held device105. It can be seen that a pressurized gas source 140A is linked to adownstream pressure regulator 205, an inflow proportional valve 246,flow meter 248 and normally closed solenoid valve 250. The valve 250 isactuated by the system operator which then allows a flow of a neutralgas from gas source 140A to circulate through flexible conduit 136 andthe device 105. The gas outflow side of the system includes a normallyopen solenoid valve 260, outflow proportional valve 262 and flow meter264 that communicate with vacuum pump or source 145. The gas can beexhausted into the environment or into a containment system. Atemperature sensor 270 (e.g., thermocouple) is shown in FIG. 4 that isconfigured for monitoring the temperature of outflow gases. FIG. 4further depicts an optional subsystem 275 which comprises a vacuumsource 280 and solenoid valve 285 coupled to the controller 140B forsuctioning steam from a uterine cavity 302 at an exterior of thedielectric structure 150 during a treatment interval. As can beunderstood from FIG. 4, the flow passageway from the uterine cavity 302can be through bore 120 in sleeve 110 (see FIGS. 2, 6 and 7) or anotherlumen in a wall of sleeve 110 can be provided.

FIGS. 8A-8D schematically illustrate a method of the invention wherein(i) the thin-wall dielectric structure 150 is deployed within a patientuterus and (ii) RF current is applied to a contained neutral gas volumein the interior chamber 152 to contemporaneously create a plasma 208 inthe chamber and capacitively couple current through the thin dielectricwall 210 to apply ablative energy to the endometrial lining toaccomplish global endometrial ablation.

More in particular, FIG. 8A illustrates a patient uterus 300 withuterine cavity 302 surrounded by endometrium 306 and myometrium 310. Theexternal cervical os 312 is the opening of the cervix 314 into thevagina 316. The internal os or opening 320 is a region of the cervicalcanal that opens to the uterine cavity 302. FIG. 8A depicts a first stepof a method of the invention wherein the physician has introduced adistal portion of sleeve 110 into the uterine cavity 302. The physiciangently can advance the sleeve 110 until its distal tip contacts thefundus 324 of the uterus. Prior to insertion of the device, thephysician can optionally introduce a sounding instrument into theuterine cavity to determine uterine dimensions, for example from theinternal os 320 to fundus 324.

FIG. 8B illustrates a subsequent step of a method of the inventionwherein the physician begins to actuate the first and second handleportions, 114 a and 114 b, and the introducer sleeve 110 retracts in theproximal direction to expose the collapsed frame 155 and thin-wallstructure 150 within the uterine cavity 302. The sleeve 110 can beretracted to expose a selected axial length of thin-wall dielectricstructure 150, which can be determined by markings 330 on sleeve 115(see FIG. 1) which indicate the axial travel of sleeve 115 relative tosleeve 170 and thus directly related to the length of deployed thin-wallstructure 150. FIG. 2 depicts the handle portions 114 a and 114 b fullyapproximated thus deploying the thin-wall structure to its maximumlength.

In FIG. 8B, it can be understood that the spring frame elements 158 a,158 b, 160 a and 160 b move the dielectric structure 150 from anon-expanded position to an expanded position in the uterine cavity asdepicted by the profiles in dashed lines. The spring force of the frame155 will expand the dielectric structure 150 until limited by thedimensions of the uterine cavity.

FIG. 8C illustrates several subsequent steps of a method of theinvention. FIG. 8C first depicts the physician continuing to actuate thefirst and second handle portions, 114 a and 114 b, which furtheractuates the frame 155 (see FIGS. 5-6) to expand the frame 155 andthin-wall structure 150 to a deployed triangular shape to contact thepatient's endometrial lining 306. The physician can slightly rotate andmove the expanding dielectric structure 150 back and forth as thestructure is opened to insure it is opened to the desired extent. Inperforming this step, the physician can actuate handle portions, 114 aand 114 b, a selected degree which causes a select length of travel ofsleeve 170 relative to sleeve 115 which in turn opens the frame 155 to aselected degree. The selected actuation of sleeve 170 relative to sleeve115 also controls the length of dielectric structure deployed fromsleeve 110 into the uterine cavity. Thus, the thin-wall structure 150can be deployed in the uterine cavity with a selected length, and thespring force of the elements of frame 155 will open the structure 150 toa selected triangular shape to contact or engage the endometrium 306. Inone embodiment, the expandable thin-wall structure 150 is urged towardand maintained in an open position by the spring force of elements ofthe frame 155. In the embodiment depicted in FIGS. 1 and 2, the handle106 includes a locking mechanism with finger-actuated sliders 332 oneither side of the handle that engage a grip-lock element against anotch in housing 333 coupled to introducer sleeve 110 (FIG. 2) to locksleeves 115 and 170 relative to introducer sleeve 110 to maintain thethin-wall dielectric structure 150 in the selected open position.

FIG. 8C further illustrates the physician expanding the expandableballoon structure 225 from inflation source 148 to thus provide anelongated sealing member to seal the cervix 314 outward from theinternal os 320. Following deployment of the thin-wall structure 150 andballoon 225 in the cervix 314, the system 100 is ready for theapplication of RF energy to ablate endometrial tissue 306. FIG. 8C nextdepicts the actuation of the system 100, for example, by actuatingfootswitch 235, which commences a flow of neutral gas from source 140Ainto the interior chamber 152 of the thin-wall dielectric structure 150.Contemporaneous with, or after a selected delay, the system's actuationdelivers RF energy to the electrode arrangement which includes firstpolarity electrode 215 (+) of frame 155 and the second polarityelectrode 220 (−) which is carried on the surface of expandable balloonmember 225. The delivery of RF energy delivery will instantly convertthe neutral gas in interior chamber 152 into conductive plasma 208 whichin turn results in capacitive coupling of current through the dielectricwall 210 of the thin-wall structure 150 resulting in ohmic heating ofthe engaged tissue. FIG. 8C schematically illustrates the multiplicityof RF current paths 350 between the plasma 208 and the second polarityelectrode 220 through the dielectric wall 210. By this method, it hasbeen found that ablation depths of 3 mm to 6 mm or more can beaccomplished very rapidly, for example in 60 seconds to 120 secondsdependent upon the selected voltage and other operating parameters. Inoperation, the voltage at which the neutral gas inflow, such as argon,becomes conductive (i.e., converted in part into a plasma) is dependentupon a number of factors controlled by the controllers 130B and 140B,including the pressure of the neutral gas, the volume of interiorchamber 152, the flow rate of the gas through the chamber 152, thedistance between electrode 210 and interior surfaces of the dielectricwall 210, the dielectric constant of the dielectric wall 210 and theselected voltage applied by the RF source 130, all of which can beoptimized by experimentation. In one embodiment, the gas flow rate canbe in the range of 5 ml/sec to 50 ml/sec. The dielectric wall 210 cancomprise a silicone material having a thickness ranging from a 0.005″ to0.015 and having a relative permittivity in the range of 3 to 4. The gascan be argon supplied in a pressurized cartridge which is commerciallyavailable. Pressure in the interior chamber 152 of dielectric structure150 can be maintained between 14 psia and 15 psia with zero or negativedifferential pressure between gas inflow source 140A and negativepressure or vacuum source 145. The controller is configured to maintainthe pressure in interior chamber in a range that varies by less than 10%or less than 5% from a target pressure. The RF power source 130A canhave a frequency of 450 to 550 KHz, and electrical power can be providedwithin the range of 600 Vrms to about 1200 Vrms and about 0.2 Amps to0.4 Amps and an effective power of 40 W to 100 W. In one method, thecontrol unit 135 can be programmed to delivery RF energy for apreselected time interval, for example, between 60 seconds and 120seconds. One aspect of a treatment method corresponding to the inventionconsists of ablating endometrial tissue with RF energy to elevateendometrial tissue to a temperature greater than 45 degrees Celsius fora time interval sufficient to ablate tissue to a depth of at least 1 mm.Another aspect of the method of endometrial ablation of consists ofapplying radiofrequency energy to elevate endometrial tissue to atemperature greater than 45 degrees Celsius without damaging themyometrium.

FIG. 8D illustrates a final step of the method wherein the physiciandeflates the expandable balloon member 225 and then extends sleeve 110distally by actuating the handles 114 a and 114 b to collapse frame 155and then retracting the assembly from the uterine cavity 302.Alternatively, the deployed working end 122 as shown in FIG. 8C can bewithdrawn in the proximal direction from the uterine cavity wherein theframe 155 and thin-wall structure 150 will collapse as it is pulledthrough the cervix. FIG. 8D shows the completed ablation with theablated endometrial tissue indicated at 360.

In another embodiment, the system can include an electrode arrangementin the handle 106 or within the gas inflow channel to pre-ionize theneutral gas flow before it reaches the interior chamber 152. Forexample, the gas inflow channel can be configured with axially orradially spaced apart opposing polarity electrodes configured to ionizethe gas inflow. Such electrodes would be connected in separate circuitryto an RF source. The first and second electrodes 215 (+) and 220 (−)described above would operate as described above to provide the currentthat is capacitively coupled to tissue through the walls of thedielectric structure 150. In all other respects, the system and methodwould function as described above.

Now turning to FIGS. 9 and 10, an alternate working end 122 withthin-wall dielectric structure 150 is shown. In this embodiment, thethin-wall dielectric structure 150 is similar to that of FIGS. 5 and 6except that the second polarity electrode 220′ that is exterior of theinternal chamber 152 is disposed on a surface portion 370 of thethin-wall dielectric structure 150. In this embodiment, the secondpolarity electrode 220′ comprises a thin-film conductive material, suchas gold, that is bonded to the exterior of thin-wall material 210 alongtwo lateral sides 354 of dielectric structure 150. It should beappreciated that the second polarity electrode can comprise one or moreconductive elements disposed on the exterior of wall material 210, andcan extend axially, or transversely to axis 111 and can be singular ormultiple elements. In one embodiment shown in more detail in FIG. 10,the second polarity electrode 220′ can be fixed on another lubriciouslayer 360, such as a polyimide film, for example KAPTON®. The polyimidetape extends about the lateral sides 354 of the dielectric structure 150and provides protection to the wall 210 when it is advanced from orwithdrawn into bore 120 in sleeve 110. In operation, the RF deliverymethod using the embodiment of FIGS. 9 and 10 is the same as describedabove, with RF current being capacitively coupled from the plasma 208through the wall 210 and endometrial tissue to the second polarityelectrode 220′ to cause the ablation.

FIG. 9 further shows an optional temperature sensor 390, such as athermocouple, carried at an exterior of the dielectric structure 150. Inone method of use, the control unit 135 can acquire temperature feedbacksignals from at least one temperature sensor 390 to modulate orterminate RF energy delivery, or to modulate gas flows within thesystem. In a related method of the invention, the control unit 135 canacquire temperature feedback signals from temperature sensor 240 ininterior chamber 152 (FIG. 6 to modulate or terminate RF energy deliveryor to modulate gas flows within the system.

In another aspect of the invention, FIG. 11 is a graphic representationof an algorithm utilized by the RF source 130A and RF controller 130B ofthe system to controllably apply RF energy in an endometrial ablationprocedure. In using the expandable dielectric structure 150 of theinvention to apply RF energy in an endometrial ablation procedure asdescribed above, the system is configured to allow the dielectricstructure 150 to open to different expanded dimensions depending on thesize and shape of the uterine cavity 302. The axial length of dielectricstructure 150 also can be adjusted to have a predetermined axial lengthextended outward from the introducer sleeve 110 to match a measuredlength of a uterine cavity. In any case, the actual surface area of theexpanded dielectric structure 150 within different uterine cavities willdiffer—and it would be optimal to vary total applied energy tocorrespond to the differing size uterine cavities.

FIG. 11 represents a method of the invention that automaticallydetermines relevant parameters of the tissue and the size of uterinecavity 302 to allow for selection of an energy delivery mode that iswell suited to control the total applied energy in an ablationprocedure. In embodiments, RF energy is applied at constant power for afirst time increment, and the following electrical parameters (e.g.,voltage, current, power, impedance) are measured during the applicationof energy during that first time increment. The measured electricalparameters are then used (principally, power and current, V=P/I) todetermine a constant voltage to apply to the system for a second timeinterval. The initial impedance may be also be utilized by thecontroller as a shutoff criteria for the second treatment interval aftera selected increase in impedance.

For example, in FIG. 11, it can be seen that a first step following thepositioning of the dielectric structure in the uterine cavity 302 is toapply radiofrequency energy in a first mode of predetermined constantpower, or constant RF energy (“FIRST MODE—POWER”). This first power issufficient to capacitively couple current across the dielectric tocontacted tissue, wherein empirical studies have shown the power can bein the range of 50 W-300 W, and in one embodiment is 80 W. This firstpower mode is applied for a predetermined interval which can be lessthan 15 seconds, 10 seconds, or 5 seconds, as examples, and is depictedin FIG. 11 as being 2 seconds. FIG. 11 shows that, in accordance withembodiments, the voltage value is determined a voltage sensor incontroller 130A and is recorded at the “one-second” time point after theinitiation of RF energy delivery. The controller includes a powersensor, voltage sensor and current sensor as is known in the art. Thisvoltage value, or another electrical parameter, may be determined andrecorded at any point during the interval, and more than one recordingmay be made, with averages taken for the multiple recordings, or themultiple recordings may be used in another way to consistently take ameasurement of an electrical value or values. FIG. 11 next illustratesthat the controller algorithm switches to a second mode (“SECONDMODE—VOLTAGE”) of applying radiofrequency energy at a selected constantvoltage, with the selected constant voltage related to the recordedvoltage (or other electrical parameter) at the “one-second” time point.In one embodiment, the selected constant voltage is equal to therecorded voltage, but other algorithms can select a constant voltagethat is greater or lesser than the recorded voltage but determined by afactor or algorithm applied to the recorded voltage. As further shown inFIG. 11, the algorithm then applies RF energy over a treatment intervalto ablate endometrial tissue. During this period, the RF energy isvaried as the measured voltage is kept constant. The treatment intervalcan have an automatic time-out after a predetermined interval of lessthat 360 seconds, 240 seconds, 180 seconds, 120 seconds or 90 seconds,as examples.

By using the initial delivery of RF energy through the dielectricstructure 150 and contacted tissue in the first, initial constant powermode, a voltage level is recorded (e.g., in the example, at one second)that directly relates to a combination of (i) the surface area of thedielectric structure, and the degree to which wall portions of thedielectric structure have been elastically stretched; (ii) the flow rateof neutral gas through the dielectric structure and (iii) the impedanceof the contacted tissue. By then selecting a constant voltage for thesecond, constant voltage mode that is directly related to the recordedvoltage from the first time interval, the length of the second,treatment interval can be the same for all different dimension uterinecavities and will result in substantially the same ablation depth, sincethe constant voltage maintained during the second interval will resultin power that drifts off to lower levels toward the end of the treatmentinterval as tissue impedance increases. As described above, thecontroller 130A also can use an impedance level or a selected increasein impedance to terminate the treatment interval.

The algorithm above provides a recorded voltage at set time point in thefirst mode of RF energy application, but another embodiment can utilizea recorded voltage parameter that can be an average voltage over ameasuring interval or the like. Also, the constant voltage in the secondmode of RF energy application can include any ramp-up or ramp-down involtage based on the recorded voltage parameter.

In general, an electrosurgical method for endometrial ablation comprisespositioning a RF ablation device in contact with endometrial tissue,applying radiofrequency energy in a first mode based on a predeterminedconstant power over a first interval, and applying radiofrequency energyin a second mode over a second interval to ablate endometrial tissuewherein the energy level of the second mode being based on treatmentvoltage parameters obtained or measured during the first interval. Powerduring the first interval is constant and power during the second periodis varied to maintain voltage at a constant level. Another step inapplying RF energy in the first mode includes the step of recording avoltage parameter in the first interval, wherein the voltage parameteris at least one of voltage at a point in time, average voltage over atime interval, and a change or rate of change of voltage. The secondmode includes setting the treatment voltage parameters in relation tothe voltage parameter recorded in the first interval.

Referring to FIG. 11, it can be understood that an electrosurgicalsystem for endometrial ablation comprises a radiofrequency ablationdevice coupled to an radiofrequency power supply, and control meansconnected to the radiofrequency power supply for switching theapplication of radiofrequency energy between a constant power mode and aconstant voltage mode. The control means includes an algorithm that (i)applies radiofrequency energy in the first mode (ii) records the voltagewithin a predetermined interval of the first mode, and (iii) appliesradiofrequency energy in the second mode with constant voltage relatedto the recorded voltage.

In another aspect, the invention comprises a radiofrequency powersupply, a means for coupling the radiofrequency power supply to anablation device configured for positioning in a uterine cavity, theablation device comprising a dielectric for contacting endometrialtissue, a system for recording an electrical parameter of the ablationdevice and contacted tissue, and a feedback system for varying theapplication of radiofrequency energy to tissue between a constant powermode and a constant voltage mode based on a recorded electricalparameter.

In another embodiment of the invention, FIGS. 12, 13A and 13B depictcomponents of the ablation device of FIGS. 1-2 that provide thephysician with an indication of the degree to which the dielectricstructure 150 has opened in the patient's uterine cavity 302. It can beunderstood from FIGS. 5, 6 and 8C that the spring frame 155 that movesthe dielectric structure 150 from a contracted, linear shape (FIG. 8B)to an expanded, triangular shape (FIG. 8C) results from actuating thehandle 106 to move the assembly of inner sleeve 170, intermediate sleeve115, frame 155 and dielectric structure 150 distally relative to theintroducer sleeve 110 to thus expose and deploy the dielectric structure150 in the uterine cavity 302.

Referring to FIG. 12, it can be seen that inner sleeve 170 andintermediate sleeve 115 are shown for convenience without theirrespective welded connections to spring frame elements 158 a, 158 b, 160a and 160 b. The frame elements 158 a, 158 b, 160 a and 160 b and theirspringing function can be seen in FIGS. 5 and 6. In FIG. 12, theintroducer sheath 110 is shown as being moved proximally relative to thedielectric structure 150 which corresponds to a position of thedielectric structure 150 shown in FIG. 8B. In the schematic view of FIG.12, the distal end 400 of sleeve 170 has an axial position X and can beapproximately the same axial position as the distal end 402 of theintroducer sleeve 110. It can be understood that when the dielectricstructure 150 and interior spring frame 155 are deployed in a uterinecavity, the spring force of frame 155 will tend to open the dielectricstructure 150 from a position in FIG. 8B toward the position of FIG. 8C.In FIG. 12, an initial position of the distal end 405 of sleeve 170 hasan axial position indicated at A which corresponds to plan shape A′ ofthe dielectric structure 150. In a typical procedure, the spring forceof frame 155 will move the distal end 405 of sleeve 170 toward an axialposition B which corresponds to expanded dielectric plan shape B′ ortoward an axial position C and corresponding expanded dielectric planshape C′. Dielectric plan shape C′ represents a fully expandeddielectric structure 150. In order to allow the spring force of frame155 to expand the frame and dielectric structure 150, the physician maygently and very slightly rotate, tilt and translate the expandingdielectric structure 150 in the uterine cavity 302. After thus deployingthe dielectric structure, the different dimensions of uterine cavitieswill impinge on the degree of expansion of the dielectric structure150—and the size and surface area of the dielectric structure, as anexample, will be within the dimension range between plan shape A′ andplan shape C′ of FIG. 12.

In one aspect of the invention, it is important for the system andphysician to understand the degree to which the dielectric structure 150and frame 155 has expanded in the uterine cavity. If the dielectricstructure 155 has not expanded to a significant degree, it may indicatethat the uterine cavity is very small or very narrow, that fibroids areimpinging on dielectric structure preventing its expansion, that theuterine cavity is very asymmetric, or that a tip of the dielectricstructure and frame 155 has penetrated into an endometrial layer,perforated the uterine wall or followed a dissection path created by asounding procedure just prior to deployment of the dielectric structure.Further, in one system embodiment, the dielectric structure 150 ispreferred to have a minimum surface area directly related to itsexpanded shape to thus cooperate with an RF energy delivery algorithm.

In one embodiment, the system provides a “degree of frame-open”signaling mechanism for signaling the physician that the frame 155 anddielectric structure 150 has expanded to a minimum predeterminedconfiguration. The signaling mechanism is based on the relative axiallocation of inner sleeve 170 and sleeve 115 as can be understood fromFIGS. 12 and 13A-13B. In FIGS. 1 and 2, it can be seen that a slidingelement 450 is exposed in a top portion of handle component 114B toslide axially in a slot 452. In a schematic view of handle component 114b in FIGS. 13A-13B, it can be seen that the proximal end 454 of sleeve115 is fixed in handle component 114 b. Further, the proximal end of 456of the inner sleeve 170 is connected to the sliding element 450 thatslides in slot 452. Thus, it can be understood that inner sleeve 170 isslidable and free-floating in the bore 175 of sleeve 115 and can bemoved axially to and fro depending to the opening spring force of frame155—which force can be constrained by the frame being withdrawn into thebore 120 of introducer sleeve 110 or by uterine walls impinging on thedielectric structure 150 and frame 155 when deployed in a uterinecavity. As can be seen in FIGS. 1, 2, 13A and 13B, the sliding elementhas at least two axially-extending indicators 460A and 460B that can bedifferent colors that slide axially relative to status-indicating arrowelement 465 in a fixed location in the handle 114 b. In one embodiment,indicator 460A can be red for “stop” and indicator 460B can be “green”,for indicating whether to stop proceeding with the procedure, or to goahead with the ablation procedure. In FIG. 13A, it can be seen thatinner sleeve 170 and its distal end 405 are only axially extended atpoint A which corresponds to dielectric expansion profile A′. Thelimited expansion of dielectric structure at profile A′ is indicated atthe slider 450 wherein the arrow 465 points to the red “stop” indicator460A which indicates to the physician to stop and not proceed with theablation procedure due to limited expansion of dielectric structure 150.

FIG. 13B depicts an extension of inner sleeve 170 and its distal end 405to axially extended at point B which corresponds to dielectric expansionprofile B′. This intermediate expansion of dielectric structure 150 atprofile B′ is indicated to the physician by observing slider 450 whereinarrow 465 points to the green indicator 460B which indicates “go”—thatis, the physician can proceed with the ablation procedure since thedielectric structure 150 and frame 155 have expanded to a predetermineddegree that cooperates with an RF energy delivery algorithm. It can beunderstood from FIG. 13B that sleeve 170 can move axially towardextended position C with corresponding dielectric structure profile C′and indicator arrow 465 will again point to the “go” portion 460B ofsliding element which is green.

In another aspect of the invention also depicted in FIGS. 13A-13B, thehandle component 114 b can include a electrical contact sensor 470 thatdetects the axial movement of sliding element 450 and sleeve 170relative to sleeve 115 to thereby provide an electronic signalindicating the degree of expansion of the frame 155 and dielectricstructure 150. In one embodiment, the electronic signal communicateswith RF controller 130B to disable the system if the relative axialpositions of sleeves 170 and 115 do not indicate a predetermined degreeof expansion of the frame 155 and dielectric structure. The system canfurther include an override mechanism, whereby the physician canmanipulate the instrument slightly back and forth and rotationally toevaluate whether the frame 155 opens incrementally more. In anotherembodiment, the electrical sensor 470 can detect a plurality of degreesof expansion of the frame 155 and dielectric structure 150, for exampleas depicted by an electrical contact be activated at positions AA, BB,CC, and DD of the slider 450 in FIGS. 13A-13B, wherein each degree ofexpansion of frame 155 signals the controller to select a different RFdelivery algorithm. The various different RF delivery algorithms canalter at least one of: (i) the duration of a treatment interval, forexample from between 60 seconds and 240 seconds, (ii) the relationbetween a recorded voltage and a treatment voltage as described in thetext accompanying FIG. 11 above (e.g., the treatment voltage can equalthe recorded voltage, or vary as a factor about 0.8, 0.9, 1.0, 1.1 or1.2 times the recorded voltage; (iv) can vary a ramp-up or ramp-down involtage, or can a time interval of the first and second modes of RFenergy delivery described above. The number of degrees of expansion offrame 155 and dielectric structure can range from 1 to 10 or more.

The embodiment of FIGS. 1, 2, 13A and 13B depict indicator subsystemsthat include visual and electrical signals, but it should be appreciatedthat the indicator subsystem can provide any single or combinationsignals that can be visual, aural or tactile with respect to theoperator and/or electrically communicate with microprocessors,programmable logic devices or controllers of the ablation system.

FIGS. 14A-14B schematically illustrate another embodiment of anelectrosurgical working end 600 that comprises a thin-wall, complaintelastomeric member 605 having an energy-delivery surface 606 that iscapable of substantially conforming to the surface of a patient'suterine cavity. The working end 600 is shown in an expandedconfiguration and can be contracted to be withdrawn into bore 608 inintroducer sleeve 610 extending along axis 615. In this embodiment, theenergy-delivery surface 606 carries at least one RF electrode coupled toa radiofrequency generator 650. In the embodiment of FIG. 14A, theelectrode's arrangement includes bi-polar electrodes consisting of firstpolarity electrode 622A and second polarity electrode 622B, for examplewith electrode elements 624 a-624 d in branches to allow lateralexpansion of the elastomeric member. The opposing side of theenergy-delivery surface 606 can have mirror image electrodes so that thebi-polar electrodes are carried in four quadrants, however the number ofelectrodes can range from 2 to 100 or more and operate with or withoutmultiplexing to apply energy to engaged tissue.

As shown in the schematic view of FIG. 15, the bi-polar electrodeassembly 622A is embedded in the elastomeric wall, such as a siliconewall. FIG. 15 illustrates an electrode foil 640 that is bonded to apolymer backing tape 642 (e.g., Kapton® or the like) and then moldedinto a balloon wall 644. The electrode foil 640 and backing tape 642 canbe acquired from a flex-circuit manufacturer, such as All Flex, 1705Cannon Lane, Northfield, Minn. 55057. The electrodes are coupled to RFsource 650 and controller by electrical leads extending through sleeve610 (FIG. 14A).

As shown in transparent view of FIG. 14B, the electrosurgical workingend 600 of FIG. 14A can be expanded by a translatable sleeve 626 andtriangular frame 625 as described in previous embodiments. The frame 625supports the electrosurgical working end 600 in an open configuration,with at least the outer portion 628 of complaint elastomeric member 605of the electrosurgical working end 600 being inflatable to engage with apatient's uterine cavity.

Referring to FIG. 14A, the expandable member 605 can carry at least onethermocouple 652 that is connected to a controller for modulatingelectrical current to the electrode arrangement. By this means, theengaged tissue can be maintained at or about a targeted temperature, forexample ranging between about 80° C. and 200° C.

FIG. 16 shows a schematic view of another working end 600′ similar tothat of FIGS. 14A-14B except that the thin-wall elastomeric structure605 is not configured with an inflatable interior chamber. Theembodiment of FIG. 16 has a surface with at least one aperture 658therein for permitting a negative pressure source 660 to be incommunication with the uterine cavity through the apertures 658. By thismeans, steam can be evacuated through the energy delivery surface 605into the interior of frame 625 that holds the working end open. Thesteam, water droplets, etc. can be evacuated through a lumen in theintroducer 610.

FIG. 17 is a schematic view of another working end 600″ similar to thatof FIG. 14A or FIG. 16 further configured with a channel 662 in theintroducer that can accommodate an elongate member 665 that carriesdistal ultrasound transducer mechanism indicated at 670. The ultrasoundtransducer 670 allows the physician to monitor the depth of ablation inreal time during an endometrial ablation procedure. In this embodiment,the ultrasound transducer 670 is re-usable and is mounted on anon-disposable tool. In another embodiment (not shown), the ultrasoundtransducer 670 can be disposable and carried within the working end.

FIGS. 18 and 19A-19B schematically illustrate another embodiment ofworking end 700 and a method of use. FIG. 18 is a transparent plan viewof an expandable dielectric member or membrane 705 carried at distal endof introducer 710 that extends along longitudinal axis 715. The workingend 700 is similar to previously described embodiments, which includesan expandable-collapsible frame of a spring material disposed within afluid-tight interior chamber 716 of an elastic dielectric member 705. Inone embodiment the frame comprises flexible outward frame elements 718 aand 718 b that can bow outwardly from a linear shape having a width W toan intermediate shape with width W′ to a fully expanded shape with widthW″ as shown in FIG. 18. The outward frame elements 718 a and 718 b areflexed outwardly by distal movement of inner frame elements 720 a and720 b that are coupled at proximal ends 722 a and 722 b to slidableinner sleeve 724. It can be understood from FIG. 18 that the distal tipsof inner frame elements 720 a and 720 b are welded to distal tips ofoutward frame elements 718 a and 718 b, respectively as indicated bywelds 728 a and 728 b. The frame elements are thus configured to providelateral expansion forces to expand the dielectric member 705 and itsablation surface 730 (FIG. 19A) laterally relative to axis 715.

FIGS. 19A-19B illustrate another aspect of the invention wherein theworking end 700, and more particularly the dielectric member 705, can beexpanded in a second direction relative to axis 715 that is transverseto plane P of the frame expansion. Stated another way, the probe workingend can be expanded anteriorly-posteriorly in the uterine cavity. FIG.19A shows the dielectric membrane 705 stretched and expanded laterallyin a first direction by the frame elements as in FIG. 18. FIG. 19B showsthe dielectric membrane 705 further expanded in the second direction byinflation of the interior chamber 716 by means of a pressured inflow ofgas from a gas inflow source 735 that is in communication with theinterior chamber. In one embodiment, the gas flow into the dielectricmember 705 comprises the Argon gas inflow that can be ionized asdescribed previously to enable the electrosurgical energy deliveryaspects of the invention.

Referring to FIG. 19B, it has been found that positive pressure in theinterior chamber 716 during operation is useful in ablating tissue sincethe positive pressure can help maintain the ablation surface 730 incontact with tissue, which in turn permits more effective capacitivecoupling through the dielectric membrane 705 and more effective passiveconductive heating from the membrane 705 which is heated by ionbombardment from the contained plasma following the plasma formation inthe interior chamber 716. In one embodiment, the pressure in the balloonis at least 20 mm Hg, at least 30 mm Hg, at least 40 mm Hg or at least50 mm Hg (above ambient). Since the Argon gas is circulating asdescribed above, the gas inflow rate and gas outflow rate can bemodulated with valve assemblies and a controller to provide apredetermined net positive pressure in the interior chamber. It also hasbeen found that positive pressure in the interior chamber 716 can beuseful in causing plasma filaments to be more uniform and more widelydispersed since the dielectric membrane 705 may be spaced away from theframe elements 720 a and 720 b in the central region of the interiorchamber.

FIG. 20 illustrates another aspect of the invention is which working end700′ has a dielectric membrane 705 has a triangular shape that is moldedto provide soft, bulbous tips 740 at each distal apex of the membranewhich assist in atraumatic introduction of the working end into theuterine cavity. In one variation, the tips 740 are soft silicone hashave a thickness overlying the frame elements of at least 0.020″, atleast 0.040″, or at least 0.060″. The tip can have an elongated bulb oroval shape. In one variation, the tips can be flattened on the interiorsides to adjoin one other when the frame is in a linear configurationfor trans-cervical introduction (see shape W in FIG. 18).

FIG. 21 illustrates another embodiment of working end similar to thosedescribed previously with a dielectric membrane that can be expanded byframe that uses frame element with dissimilar spring characteristics toalter the expanded plan shape or the dielectric membrane structure tocorrespondingly increase the surface area of the energy delivery surface(for any given axial length of the dielectric membrane) to optimizeenergy delivery to engaged tissue. In FIG. 21, the working end 800carries an expandable dielectric structure or membrane 805 at the distalend of introducer 810. The dielectric membrane is shown in a selectedexpanded shape having an axial length AL. It should be appreciated thatthe axial length can be adjusted between about 4 cm and 6.5 cm bycontrolling the length of the frame and dielectric membrane 805 that ispermitted to extend outward from the distal end 812 of introducer sleeve810 along longitudinal axis 815. The working end 800 is similar topreviously described embodiments, wherein the expandable-collapsibleframe is fabricated of a spring material disposed within the fluid-tightinterior chamber 816 of the dielectric membrane 805. In one variation,the flexible outward frame elements 818 a and 818 b flex and bowoutwardly from a linear non-deployed shape when actuated by inner frameelements 820 a and 820 b that are coupled at proximal ends 822 a and 822b to slidable inner sleeve 824. The outer frame elements 818 a and 818 bare thus configured to directly engage the dielectric and apply lateralexpanding forces to expand the dielectric membrane 805 and its ablationsurface 830 to contact endometrial tissue. In one variation, referringto FIG. 21, the outer frame elements 818 a and 818 b can be 304 SS or316 SS with a thickness of less than 0.012″ and a width ranging between2.5 mm and 5.0 mm. The inner frame elements 820 a and 820 b are adissimilar material that is configured to actuate and flex the outerframe elements and therefore has a thickness greater than 0.012″. Theouter elements can have a thickness ranging between 0.004″ and 0.012″.In one variation, the inner frame elements 820 a and 820 b have athickness in the range of 0.012″ to 0.020″. In one variation, the innerframe elements 820 a and 820 b are 0.018″ thickness NanoFlex® materialmanufactured by Sandvik Materials Technology, Åsgatan 1 SE-81181,Sandviken, Sweden. Sandvik's Nanoflex is a precipitation hardenablestainless steel specifically designed for applications requiring highstrength, an absence of softening after exposure to high temperatures,and excellent weldability. The use of the dissimilar frame materialsallows for the frame to expand as shown in FIG. 21 with lateral sidesbeing relatively linear instead of being deeply bowed inwardly. Thus,the more triangular shape allows for an increased total surface area ofthe dielectric in contact with tissue when compared with a variationthat has more deeply bowed outer frame elements (cf. FIG. 20).

In general, the endometrial ablation device comprises an elongated shaftwith a working end having an axis and comprising a compliantenergy-delivery surface (of the dielectric) actuatable by an interiorexpandable-contractible frame, the surface being expandable to aselected planar triangular shape configured for deployment to engage thewalls of a patient's uterine cavity, and wherein the frame has flexibleouter elements in lateral contact with the compliant surface andflexible inner elements not in said lateral contact, wherein the innerand outer elements have substantially dissimilar material properties. Inthis variation, the energy-delivery surface is configured for primaryexpansion in a lateral direction by the frame wherein axial movement ofthe inner elements moves the outer elements laterally. In thisvariation, the inner frame elements have a higher spring constant thanthe outer frame elements. In this variation, the inner frame elementshave a plastic deformation range greater than the outer frame elements.In this variation, the inner frame elements are configured to maintaintheir spring function at operating temperatures of the system.

In another variation, an endometrial ablation device comprises anelongated shaft with a working end having an axis and comprising acompliant energy-delivery surface actuatable by an interiorexpandable-contractible frame, the surface being expandable to aselected planar triangular shape configured for deployment to engage thewalls of a patient's uterine cavity, and wherein the selected shape canhave an axial length ranging at least between 4.5 cm and 6.5 cm. In thisvariation, the selected shape can have a width between a first apex andsecond apex ranging at least between 2.5 cm and 5 cm.

In one embodiment of working end, the compliant surface comprises adielectric with a surface area of at least 25 cm². This embodiment can asurface area ranging at least between 25 cm² and 30 cm².

In one variation of working end, the compliant surface has a surfacearea of at least 22 cm² when the selected length is 4.0 cm. In thisvariation, the compliant surface has a surface area of at least 23 cm²when the selected length is 4.5 cm. In this variation, the compliantsurface has a surface area of at least 24 cm² when the selected lengthis 5.0 cm. In this variation, the compliant surface has a surface areaof at least 25 cm² when the selected length is 5.5 cm. In thisvariation, the compliant surface has a surface area of at least 26 cm²when the selected length is 6.0 cm. In this variation, the compliantsurface has a surface area of at least 27 cm² when the selected lengthis 6.5 cm.

In another variation of working end, the compliant surface has a ratioof “surface area to axial length” of at least 4.5:1 in any selectedaxial length ranging from 4.5 cm to 6.5 cm.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are present in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modification and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

What is claimed is:
 1. A method for endometrial ablation comprising:expanding frame within a compliant energy-delivery surface to a planartriangular shape to engage the walls of a patient's uterine cavity;wherein the frame has flexible outer elements in lateral contact withthe compliant surface and flexible inner elements not in said lateralcontact, wherein the inner and outer elements have substantiallydissimilar material properties.